ClinicalTrials.gg
RecruitingNCT06375941ProStarsUpdated Nov 20, 2025

Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars

An observational study in Angiosarcoma, sponsored by Italian Sarcoma Group. Recruiting at 19 sites in Italy. Per ClinicalTrials.gov, last updated 2025-11-20.

Sponsored by Italian Sarcoma Group · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
250
Sex
All
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Study summary

This study will be a multi-institutional, prospective, observational study of patients with localized primary AS of any site within ISG and RTR centers. Patients will be treated according to clinical practice of the center and according to ISG clinical recommendations on localized AS.

Read the detailed description

The management of localized AS remains a clinical challenge and needs to be better defined and standardized, especially with regards to the role of radiation-therapy and systemic treatment. Several questions about the best treatment approach to some clinical presentations remain open and would need to be answered by clinical studies. Unfortunately, the rarity of this histology among sarcomas makes it challenging to carry out clinical studies in all such presentations. Moreover, prognostic factors are lacking and differences in epidemiological, pathological and clinical aspects between primary AS and secondary AS need to be better characterized.

These issues may be addressed with a prospective multi-institutional observational study, through the collection of clinical and pathological data of patients with localized AS.

Involving all reference centres for sarcoma in Italy, the Italian Sarcoma Group (ISG) will be the ideal network for this study, with the collaboration of the Italian Rare Cancer Network (RTR), a 7collaborative network among Italian centres focusing on improving the quality of care of patients with rare tumors.

02

Conditions studied

  • Angiosarcoma

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03

In context

Hemangiosarcoma

99 studies on the registry are indexed under Hemangiosarcoma; 16 are open to participants now.

Browse Hemangiosarcoma studies →

Lead sponsor

Italian Sarcoma Group is the lead sponsor of 31 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  • pathological diagnosis of AS;
  • any site of origin;
  • any age;
  • primary, localized, resectable disease.

Eligibility criteria

Inclusion Criteria:

  • pathological diagnosis of AS;
  • any site of origin;
  • any age;
  • primary, localized, resectable disease.

Exclusion Criteria: NA

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • Pathological diagnosis of AS, any site of origin, any age, primary, localized, resectable disease.

    * pathological diagnosis of AS; * any site of origin; * any age; * primary, localized, resectable disease.

    Other: Observational

Interventions

  • OtherObservational

    Observational

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What researchers measure

Primary outcomes

  1. Demographic characteristics

    Demographic data

    Time frame: At the time of enrollment

  2. General characteristics

    Comorbidities

    Time frame: At the time of enrollment

  3. Cancer data

    Previous cancer data

    Time frame: At the time of enrollment

  4. Origin of Tumor

    Site of origin

    Time frame: At the time of enrollment

  5. Tumor characteristics

    Multifocality

    Time frame: At the time of enrollment

  6. Tumor size

    Size

    Time frame: At the time of enrollment

  7. Tumor aspects

    Morphological aspects

    Time frame: 10 years

  8. Pathological characteristics

    Proliferative index

    Time frame: 10 years

  9. Tumor phenotype

    Tumor cell phenotype

    Time frame: 10 years

  10. Molecular characteristics

    Molecular aspects

    Time frame: 10 years

07

Study locations

12 of 19 sites recruiting
  • Istituto Clinico Humanitas Research Hospital IRCCS
    Rozzano, Milano 20089, Italy
    Not yet recruiting
    • Alexia Bertuzzi, MD · Contact
  • Centro Riferimento Oncologico CRO
    Aviano, Pordenone 33081, Italy
    Recruiting
    • Federico Navarria, MD · Contact
  • AOU San Luigi Gonzaga
    Orbassano, Torino 10043, Italy
    Recruiting
    • Lorenzo D'Ambrosio, MD · Contact
  • Istituto Tumori "Giovanni Paolo II" I.R.C.C.S.
    Bari, 70124, Italy
    Not yet recruiting
    • Sabino Strippoli, MD · Contact
  • Istituto Ortopedico Rizzoli IOR
    Bologna, 40136, Italy
    Recruiting
    • Toni Ibrahim, MD · Contact
  • Policlinico "Sant'Orsola-Malpighi"
    Bologna, 40138, Italy
    Recruiting
    • Maria Abbondanza Pantaleo, Prof. · Contact
  • A.O.U. Careggi
    Florence, 50134, Italy
    Not yet recruiting
    • Lorenzo Livi, MD · Contact
  • Ospedale Policlinico san Martino IRCCS
    Genova, 16132, Italy
    Recruiting
    • Danila Comandini, MD · Contact
  • IRCCS Istituto Nazionale Tumori - Milano
    Milan, 20133, Italy
    Recruiting
    • Palassini Elena · Contact
  • IRCCS Istituto Europeo di Oncologia
    Milan, 20141, Italy
    Not yet recruiting
    • Elisabetta Pennacchioli, MD · Contact
  • Fondazione Irccs San Gerardo Dei Tintori
    Monza, 20900, Italy
    Not yet recruiting
    • Marinella Mastore, MD · Contact
  • Istituto Nazionale Tumori_Fondazione "G.Pascale"
    Naples, 80131, Italy
    Recruiting
    • Lucia Cannella, MD · Contact
  • IOV Istituto Oncologico Veneto IRCCS
    Padova, 35128, Italy
    Recruiting
    • Antonella Brunello · Contact
  • Policlinico "Paolo Giaccone"
    Palermo, 90127, Italy
    Recruiting
    • Giuseppe Badalamenti, Prof. · Contact
  • Nuovo Ospedale di Prato - S. Stefano
    Prato, 59100, Italy
    Recruiting
    • Giacomo Giulio Baldi · Contact
  • Fondazione Policlinico Campus Biomedico
    Roma, 00128, Italy
    Recruiting
    • Bruno Vincenzi, prof · Contact
  • IRCCS Istituti Fisioterapici Ospitalieri
    Roma, 00144, Italy
    Not yet recruiting
    • Virginia Ferraresi, MD · Contact
  • ASL Ospedale San Giovanni Bosco
    Torino, 10154, Italy
    Recruiting
    • Antonella Boglione, MD · Contact
  • Ospedale di Trento
    Trento, 38123, Italy
    Not yet recruiting
    • Marco Cianchetti, MD · Contact
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06375941
Lead sponsor
Italian Sarcoma Group
Responsible party
Sponsor
First posted
Apr 19, 2024
Start date
Mar 29, 2024
Primary completion
Apr 1, 2029 (estimated)
Completion
Apr 1, 2034 (estimated)
Last update
Nov 20, 2025

Study contacts

Gianluca Ignazzi
Contact
gianluca.ignazzi@italiansarcomagroup.org
+393335359192
Elena Palassini
principal investigator · IRCCS Istituto nazionale Tumori - Milano

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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